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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(K) Number K033636
Device Name AMS LARGE PORE POLYPROPYLENE MESH
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Contact elsa a linke
Regulation Number878.3300
Classification Product Code
OTP  
Subsequent Product Code
OTO  
Date Received11/19/2003
Decision Date 12/31/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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